Integer’s Tijuana-North facility is the first-Class III active implantable medical device manufacturing site in Mexico to receive FDA approval. This added capacity includes Class 7 and 8 clean rooms, manufacturing facility and capital equipment investment, and provides options for meaningful future expansion. It augments the significant IPG manufacturing capacity already available at Integer’s Montevideo, Uruguay, and Plymouth, Minn., facilities, offering customers dual-site manufacturing capabilities to mitigate risk.
“Integer’s key objective is to assist OEMs in bringing their innovative therapies to market efficiently, reliably and cost effectively.” said Joel Becker, president of Integer’s Cardiac Rhythm Management and Neuromodulation business. “This regulatory approval and facility expansion help us offer our customers expanded capacity and flexibility.”
The site is supported by onsite engineering and technical as well as operational staff members trained from Integer’s Research and Development Center of Excellence for IPG. Additional in-house facility capability will be in place in the Tijuana-North facility by mid-2020.
The expansion will allow customers to continue to benefit from Integer’s vertically integrated supply chain for critical IPG components, including batteries, feedthroughs and enclosures, some of which are also manufactured in the Tijuana-North facility.
“We continue to make strategic investments to support our customers’ growth and advance us toward our vision of being our customers’ partner of choice for innovative medical technologies,” said Becker. “Integer’s goal is to offer best-in-class quality, service and value, and support our customers with the most comprehensive design, development and manufacturing services available for Class III medical device systems.”
Production is managed under Integer’s Manufacturing Excellence strategies, and the manufacturing cell layout design was developed under the guidance of Integer’s Lean Center of Excellence.